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Active, Not Recruiting

NCT Number: NCT06087133

Prenatal Starting Early Program mHealth

The purpose of this interventional trial is to test the efficacy of the remote delivery of the StEP:Prenatal intervention compared to standard prenatal care in pregnant individuals planning to receive prenatal and pediatric care at Bellevue Hospital. The primary aims are to determine the efficacy of the remotely delivered StEP:Prenatal intervention on diet, lifestyle behaviors, social determinants of health (SDoH), and pregnancy outcomes.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pregnancy

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NYC Health + Hospitals/Bellevue

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Currently pregnant in the first trimester (up to 13 weeks, 6 days)
  • Speak English or Spanish fluently
  • Intent to receive prenatal and pediatric care at Bellevue
  • ≥18 years
  • Have a smart phone or device with internet access
  • Willing and able to provide consent

Exclusion criteria

  • Severe illness (severe medical or mental health condition e.g. cancer, epilepsy neuromuscular disease, psychosis or bipolar disorder).

Note: Diabetes, hypertension, depression are not excluded.

  • Living in a shelter
  • Receiving treatment for drug or alcohol use

Treatment and study plan

StEP:Prenatal

Behavioral

StEP is a health care-based intervention based on elements of Social Cognitive Theory, in which registered dietitians with additional certified lactation counselor training (RD/CLC) provide individual and group-based support for healthy diet, physical activity, other lifestyle behaviors, stress reduction, and healthy gestational weight gain. StEP:Prenatal will be delivered remotely. There are up to 8 sessions scheduled around the routine prenatal care visits and designed to be offered from the first trimester of pregnancy through delivery.

Routine care

Other

Routine care includes routine prenatal and post-partum primary care visits, on-site WIC services and referrals for additional services as needed (e.g., women with poor weight gain, obesity, or diabetes may be offered additional nutrition visits).

Primary outcomes

  1. Daily servings of fruits (cup equivalents)

    Time frame: Week 28-42 (third trimester)

    As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions.

    Self-reported by each participant via DHQ III.

  2. Daily servings of whole grains (ounce equivalents)

    Time frame: Week 28-42 (third trimester)

    As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions.

    Self-reported by each participant via DHQ III.

  3. Daily servings of refined grains (ounce equivalents)

    Time frame: Week 28-42 (third trimester)

    As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions.

    Self-reported by each participant via DHQ III.

  4. Daily servings of dairy (total milk cup equivalents)

    Time frame: Week 28-42 (third trimester)

    As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions.

    Self-reported by each participant via DHQ III.

  5. Daily servings of vegetables (cup equivalents)

    Time frame: Week 28-42 (third trimester)

    As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions.

    Self-reported by each participant via DHQ III.

  6. Number of times 100% pure fruit juice consumed

    Time frame: Week 28-42 (third trimester)

    Self-reported using survey items from the Behavioral Risk Factor Surveillance System (BRFSS).

    The question is related to 100% fruit juice consumed during the past 30 days.

  7. Number of times sugar sweetened beverages (not including 100% fruit juice) consumed

    Time frame: Week 28-42 (third trimester)

    Self-reported using survey items from the Behavioral Risk Factor Surveillance System (BRFSS).

    The questions are related to sugar sweetened beverages (not including 100% fruit juice) consumed during the past 30 days.

  8. Daily servings of protein foods (ounce equivalents)

    Time frame: Week 28-42 (third trimester)

    As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions.

    Self-reported by each participant via DHQ III.

  9. Healthy Eating Index (HEI)-2015 score

    Time frame: Week 28-42 (third trimester)

    The HEI-2015 measures 13 components (9 adequacy [total fruits, whole fruits, total vegetables, greens and beans, whole grains, dairy, total protein foods, seafood and plant proteins, fatty acids], and 4 moderation [refined grains, sodium, saturated fat, added sugars]. For the adequacy components, higher scores indicate higher intakes. For the moderation components, higher scores reflect lower intakes. Scores for each component are summed to create a total maximum HEI-2020 score of 100 points, with a higher score reflecting a dietary pattern that better aligns with the dietary guidelines.

    HEI scores range from 0 to 100, with higher scores indicating better diet quality. HEI scores > 80 indicate a "good" diet, scores ranging from 51 to 80 reflect a diet that "needs improvement," and HEI scores < 51 imply a "poor" diet (7).

  10. Daily servings of fruits (cup equivalents)

    Time frame: 3 months (6-14 weeks postpartum)

    As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions.

    Self-reported by each participant via DHQ III.

  11. Daily servings of whole grains (ounce equivalents)

    Time frame: 3 months (6-14 weeks postpartum)

    As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions.

    Self-reported by each participant via DHQ III.

  12. Daily servings of refined grains (ounce equivalents)

    Time frame: 3 months (6-14 weeks postpartum)

    As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions.

    Self-reported by each participant via DHQ III.

  13. Daily servings of dairy (total milk cup equivalents)

    Time frame: 3 months (6-14 weeks postpartum)

    As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions.

    Self-reported by each participant via DHQ III.

  14. Daily servings of vegetables (cup equivalents)

    Time frame: 3 months (6-14 weeks postpartum)

    As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions.

    Self-reported by each participant via DHQ III.

  15. Daily servings of protein foods (ounce equivalents)

    Time frame: 3 months (6-14 weeks postpartum)

    As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions.

    Self-reported by each participant via DHQ III.

  16. Number of times 100% pure fruit juice consumed

    Time frame: 3 months (6-14 weeks postpartum)

    Self-reported using survey items from the Behavioral Risk Factor Surveillance System (BRFSS).

    The question is related to 100% fruit juice consumed during the past 30 days.

  17. Number of times sugar sweetened beverages (not including 100% fruit juice) consumed

    Time frame: 3 months (6-14 weeks postpartum)

    Self-reported using survey items from the Behavioral Risk Factor Surveillance System (BRFSS).

    The questions are related to sugar sweetened beverages (not including 100% fruit juice) consumed during the past 30 days.

  18. Healthy Eating Index (HEI)-2015 score

    Time frame: 3 months (6-14 weeks postpartum)

    The HEI-2015 measures 13 components (9 adequacy [total fruits, whole fruits, total vegetables, greens and beans, whole grains, dairy, total protein foods, seafood and plant proteins, fatty acids], and 4 moderation [refined grains, sodium, saturated fat, added sugars]. For the adequacy components, higher scores indicate higher intakes. For the moderation components, higher scores reflect lower intakes. Scores for each component are summed to create a total maximum HEI-2020 score of 100 points, with a higher score reflecting a dietary pattern that better aligns with the dietary guidelines.

    HEI scores range from 0 to 100, with higher scores indicating better diet quality. HEI scores > 80 indicate a "good" diet, scores ranging from 51 to 80 reflect a diet that "needs improvement," and HEI scores < 51 imply a "poor" diet (7).

  19. Total amount of screen time

    Time frame: Week 28-42 (third trimester)

    Self-reported using survey items from the Behavioral Risk Factor Surveillance System (BRFSS).

    The questions are related to daily activities, physical activities, and sedentary activities.

  20. Total amount of physical activity

    Time frame: Week 28-42 (third trimester)

    Self-reported using survey items from the Behavioral Risk Factor Surveillance System (BRFSS).

    The questions are related to daily activities, physical activities, and sedentary activities.

  21. Total amount of screen time

    Time frame: 3 months (6-14 weeks postpartum)

    Self-reported using survey items from the Behavioral Risk Factor Surveillance System (BRFSS).

    The questions are related to daily activities, physical activities, and sedentary activities.

  22. Total amount of physical activity

    Time frame: 3 months (6-14 weeks postpartum)

    Self-reported using survey items from the Behavioral Risk Factor Surveillance System (BRFSS).

    The questions are related to daily activities, physical activities, and sedentary activities.

Secondary outcomes

  1. Patient Health Questionnaire (PHQ-9) score

    Time frame: Week 28-42 (third trimester)

    Patient Health Questionnaire-9 (PHQ-9) measures depressive symptoms and consists of 9 items.

    The PHQ-9 total score ranges from 0 to 27 (scores of 5-9 are classified as mild depressive symptoms; 10-14 as moderate depressive symptoms; 15-19 as moderately severe depressive symptoms; ≥ 20 as severe depressive symptoms).

  2. Patient Health Questionnaire (PHQ-9) score

    Time frame: 3 months (6-14 weeks postpartum)

    Patient Health Questionnaire-9 (PHQ-9) measures depressive symptoms and consists of 9 items.

    The PHQ-9 total score ranges from 0 to 27 (scores of 5-9 are classified as mild depressive symptoms; 10-14 as moderate depressive symptoms; 15-19 as moderately severe depressive symptoms; ≥ 20 as severe depressive symptoms).

  3. Generalized Anxiety Disorder-7 score

    Time frame: Week 28-42 (third trimester)

    Generalized Anxiety Disorder-7 score (GAD-7) measures anxiety symptoms and consists of 7 items.

    The GAD-7 total score ranges from 0 to 21 (scores of 0-4 are classified as minimal anxiety symptoms; 5-9 as mild anxiety symptoms; 10-14 as moderate anxiety symptoms; 15-21 as severe anxiety symptoms).

  4. Generalized Anxiety Disorder-7 score

    Time frame: 3 months (6-14 weeks postpartum)

    Generalized Anxiety Disorder-7 score (GAD-7) measures anxiety symptoms and consists of 7 items.

    The GAD-7 total score ranges from 0 to 21 (scores of 0-4 are classified as minimal anxiety symptoms; 5-9 as mild anxiety symptoms; 10-14 as moderate anxiety symptoms; 15-21 as severe anxiety symptoms).

  5. Perceived Stress Scale score

    Time frame: Week 28-42 (third trimester)

    Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

  6. Perceived Stress Scale score

    Time frame: 3 months (6-14 weeks postpartum)

    Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

  7. Family Resilience score

    Time frame: Week 28-42 (third trimester)

    An overall family resilience score is calculated using the mean from each of the participants' responses to the 4 items. Scores range from 0 to 4. Higher scores indicate greater family resilience.

  8. Family Resilience score

    Time frame: 3 months (6-14 weeks postpartum)

    An overall family resilience score is calculated using the mean from each of the participants' responses to the 4 items. Scores range from 0 to 4. Higher scores indicate greater family resilience.

  9. Gestational weight gain

    Time frame: 3 months (6-14 weeks postpartum)

  10. Total number of remote StEP:Prenatal sessions attended

    Time frame: 3 months (6-14 weeks postpartum)

  11. Total number of pregnancy care visits attended

    Time frame: 3 months (6-14 weeks postpartum)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • United States Department of Agriculture (USDA)

Registry information

Official study title

Prenatal Starting Early Program: Randomized Controlled Trial of an mHealth Intervention in Prenatal Care and Wic to Improve Nutrition and Physical Activity During Pregnancy

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 17, 2023
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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